Kornimate/medical-research-clean huggingface dataset:
the effectivity and safety study of rexenatide-4 in chinese type 2 diabetes mellitus

Conditions: Type2 Diabetes Mellitus

Summary: this research is a randomized, double-blind,controlled trial. 456 chinese subjects with type 2 diabetes mellitus will be enrolled in the trial.

this is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of re-4 as compared to placebo in patients with type 2 diabetes. patients will be randomized into one of two re-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.

Eligibility criteria:
inclusion criteria: 1. t2dm 2. 7.0% ≤ hba1c ≤ 11.0% at screening 3. fpg ≤13.8 mmol/l 4. 19 kg/m2 \< bmi \<35.0 kg/m2 at screening 5. all subjects provided written informed consent before participation exclusion criteria: 1. t1dm 2. patients treated previously with exenatide or glp-1 similar 3. at screening visit alanine aminotransferase (alt) or alkaline phosphatase (ast) more than 2.5 uln 4. at screening visit estimated glomerular filtration rate (egfr) ≤ 60 ml/min or triglyceride(tg)≥ 5 mmol/l 5. pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases 6. within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period 7. history of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones) 8. patients with severe renal impairment or end-stage renal disease 9. uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmhg or diastolic blood pressure above 110 mmhg) at screening visit. 10. use of weight loss drugs within 3 months prior to screening visit 11. have been treated with exogenous insulin, α-glucosidase, corticosteroid, dpp-4 inhibitor or pramlintide acetate within the 3 months prior to screening. 12. severe gastrointestinal disease (e.g., gastroparesis) 13. pregnancy or lactation, women of childbearing potential with no effective contraceptive method 14. participant who participated in any drug clinical trial within the last 3 months prior to screening visit 15. history of severe hypersensitivity to rexenatide-4 or any product components

Keywords: re-4 exenatide metformin sulfonylurea
preventing acute kidney injury

Conditions: Acute Kidney Injury

Summary: acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. biomarkers for acute kidney injury are well elevated before rise in creatinine. hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.

the propose study is to incorporate an alert system in current medical health system and an algorithm will be used to activate clinicians and nephrologist to confirm if patient is at high risk. once identified as high risk the clinician and/or nephrologist will intervene and change current management if needed. first phase of study will look at an alert system and algorithm was enough to lower incidence of acute kidney injury. phase 2 will also use alert system and algorithm that will be further randomized those that are identified as high risk for acute kidney injury to remote ischemic preconditioning.

Eligibility criteria:
inclusion criteria: * any admitted patients that are not excluded by exclusion criteria * patients who's creatinine returns to baseline after admitted can be included in study if patient still remains admitted. exclusion criteria: * end stage renal disease * estimated glomerular filtration rate less then 20 * left ventricular assist device patients * observation status * hospice patients * pregnancy * age less then 18 * acute kidney injury on admission defined as 1.5 times elevated creatinine prior to last admission's creatinine * nephrology consult already placed * renal transplant or nephrectomy within 1 year * patients unable to provide consent exclusion for remote ischemic preconditioning in addition to above exclusion will be: * symptoms or diagnosis of peripheral arterial disease * patients in shock defined by requiring inotropes or vasopressors
obsidio™ conformable embolic registry

Conditions: Hypervascular Tumors; Bleeding; Hemorrhage

Summary: occlude is a prospective, post-approval, open-label, single arm, multi-center us registry of patients who undergo embolization with obsidio™ conformable embolic. the purpose of this registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with obsidio.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years of age * signed informed consent\* * patient is to undergo or has undergone embolization with obsidio™ conformable embolic * patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure exclusion criteria: * patient has a life expectancy \< 30 days * contraindications to receiving obsidio™ conformable embolic per the instructions for use (ifu) * embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula) * patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels
sensory reconstruction of finger pulp defect using a dorsal digital island flap

Conditions: Trauma

Summary: sensory reconstruction of the finger pulp is a challenging problem. this article reports repair of the finger pulp defect using the dorsal digital island flap. both dorsal branches of the proper digital nerves (pdns) were used for maximal sensory restoration.

from february 2008 to may 2009, the flap harvested from the dorsum of the middle phalanx of the same finger was used in 12 fingers in 12 patients. the flaps ranged in size from 2.0 × 2.0 cm to 2.8 × 2.2 cm. the mean pedicle length was 1.2 cm. neurorrhaphy between the dorsal branches of the pdn and pdn was performed in both sides in all cases. sensibility of the reconstructed finger pulp was evaluated by static 2-point discrimination (2pd) and semmes-weinstein monofilament test. the range of motion of the donor fingers was measured. the data were compared to those of the opposite sides.

Eligibility criteria:
inclusion criteria: 1. a finger pulp defect \> 1.5 cm in length 2. necessity to preserve finger length 3. patients younger than 60 years . exclusion criteria: 1. injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site 2. injury to the course of the vascular pedicle or opposite pda 3. defects \< 1.5 cm in length.

Keywords: finger pulp reconstruction dorsal branch proper digital nerve palmar arterial arch dorsal digital island flap
brain imaging study in subjects with alzheimer disease in comparison to healthy subjects

Conditions: Alzheimer's Disease

Summary: the underlying goal of this study is to assess 123-i mni-168 spect imaging as a tool to detect ß-amyloid deposition in the brain of alzheimer's disease (ad) research participants and similarly aged and gender matched healthy subjects.

the overall research questions to be addressed by this protocol are as follows: * to assess the dynamic uptake and washout of (123i) mni-168, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (spect) in alzheimer's (ad) subjects and similarly aged and gender matched healthy controls. * to perform blood metabolite characterization of (123i) mni-168 in healthy and ad subjects to determine the metabolic fate and nature of metabolites in assessment of (123i) mni-168 as a single photon computed tomography (spect) brain imaging agent. * to acquire initial safety data following injection of (123i) mni-168. * obtain test/retest reproducibility information in ad subjects with (123i) mni-168 based on initial studies.

Eligibility criteria:
inclusion criteria: * subjects who have a clinical diagnosis of ad will be recruited for this study * the participant is 50 years or older * written informed consent is obtained * participants have a clinical diagnosis of probable alzheimer's disease based on national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria * subjects will have a clinical dementia rating (cdr) assessment score of ≥ 0.5 and \< 2.0 * modified hachinski ischemia scale score of ≤ 4 * for females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-i mni-168 injection exclusion criteria: * the subject has signs or symptoms of another neurodegenerative disease including parkinson's disease, diffuse lewy body dementia, or history of significant cerebrovascular disease * the subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness * the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery) * the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease * the subject has participated in another clinical study within the previous 30 days * clinically significant mri evidence of vascular disease or alternative neurologic disorder * pregnancy

Keywords: alzheimer disease
course for brain fatigue after graves' disease controlled study

Conditions: Graves Disease

Summary: background. mental fatigue (mf) is common in the most common form of hyperthyroidism, graves' disease (gd). clinically, mf is the primary mental symptom in patients with gd and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. it may be the main contributing factor to the continued low quality of life in many patients with gd. mf can be measured with an mf score (mfs). the pathophysiology is unknown. there is no medical treatment, which requires patients to adapt to the situation. aim. in this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (qol), and function - in patients with persistent mental fatigue in gd, through an mf course as an addition to standard care, compared to patients who receive only standard care. the investigators also test the hypothesis that the mf course is a cost-effective intervention. method. in a randomized controlled study, the investigators evaluate the effect of the mf course compared to standard care only in 96 patients with persistent mf in gd. markers of mental health, qol, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. the primary outcome measure is mfs at 3 months. clinical significance. patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. our research group is working to address the cause of mf in gd and also to alleviate the symptoms. the mf course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. our involvement in regional/national working groups will facilitate implementation in other units. in this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (qol), and function - in patients with persistent mental fatigue at gd, through an mf course as an addition to regular healthcare, compared to patients receiving only regular healthcare.


Eligibility criteria:
inclusion criteria: * 18-72 years old * 15-72 months since first graves' diagnosis * high free thyroxin and thyroid antibodies (trab) at diagnosis * euthyroid the last 6 months normal thyroid hormone levels at inclusion * symptoms on mf in connection to graves diagnosis * mf-scale ≥10.5 points exclusion criteria: * other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease) * pregnancy * lactation * assessment that the patient cannot follow the study protocol.

Keywords: mental fatigue
validation of pre-clinical nano-based analgesics in cells from human dorsal root ganglia

Conditions: Spinal Cord Neoplasm

Summary: this study investigates the pre-clinical nano-based analgesics in cells from human dorsal root ganglia (clusters of neurons). collecting these neurons may help future research related to safe and effective pain treatment.

primary objective: i. to identify translational mechanisms and therapeutics for neuropathic pain, a type of chronic pain that can arise due to injured nerves. outline: patients' leftover dorsal root ganglia samples are collected during standard of care surgery.

Eligibility criteria:
inclusion criteria: ---all patients undergoing surgery to resect spinal tumors exclusion criteria: ---none
feasibility of sbirt-pn

Conditions: Substance Use; HIV/AIDS; Older Adults; Behavioral Intervention; Infectious Disease

Summary: substance misuse is a common problem among hiv+ individuals. research suggests that a screening, brief intervention, and treatment (sbirt) model can be effective in reducing substance misuse in the general older adult population; however these findings have not been verified in the more vulnerable hiv+ older adult population. the present study seeks to address the problem of substance misuse in older hiv+ adults by piloting a sbirt model for older hiv+ adults in a in a primary care setting. individual reductions in alcohol and drug use can have significant effects on public health and safety when observed over a large population at risk for substance use problems. with wider dissemination statewide, a relatively low-cost intervention such as sbirt could offer demonstrated benefits in this population.

the current project will pilot sbirt with a peer navigator (sbirt-pn) versus treatment at usual (tau) to increase substance use treatment engagement among hiv-positive adults aged 50 years and older. the investigators will recruit patients from the southern hiv and alcohol research consortium (sharc) hiv primary care clinic network. in order to develop effective substance use intervention models for hiv care settings the specific aims of the current project are: aim1: examine the feasibility of the sbirt-pn model at the uf health infectious disease-medical specialties clinic. the investigators hypothesize that the sbirt-pn model will demonstrate high feasibility within the uf health infectious disease - medical specialties clinic. aim2a: assess the acceptability of sbirt-pn. the investigators hypothesize that sbirt-pn will demonstrate high acceptability among patients enrolled in this condition. aim2b: assess the acceptability of sbirt-pn among hiv-positive individuals by age cohort (younger vs older). the investigators hypothesize that sbirt-pn will demonstrate higher acceptability among older hiv-positive patients enrolled in this condition. aim3: assess influence of sbirt-pn model on treatment engagement and substance use compared to enhanced treatment as usual (tau).the investigators hypothesize that those in the sbirt-pn condition will evidence greater treatment engagement and a reduction in substance use.

Eligibility criteria:
inclusion criteria: * receiving care at an infectious disease medical clinic * hiv-positive (seropositive confirmed by medical records) * have a substance misuse screening score indicating moderate or high risk. exclusion criteria: * lack fluency in english * are unwilling to provide information for follow-up * plan to leave the area within 6 months * already have a referral to treatment from another provider * unable to provide informed consent due to cognitive impairment.
adherence to inhaled corticosteroids in asthma

Conditions: Medication Adherence; Asthma

Summary: it is widely recognized that asthma in adult african american patients is a significant health problem, which is partly affected by relatively low inhaled corticosteroid (ics) adherence rates. the goal of this study is to pilot test an ics adherence intervention, arica, that aims to improve ics adherence in adult african americans.

the investigators will evaluate arica in duke primary care clinics to study its feasibility and acceptability using a quasi-experimental pre-post study design. the study will enroll between 32 and 48 adult african americans with persistent asthma and suboptimal ics adherence, and their health care providers, to study the use of the intervention and key indicators of the intervention's potential effectiveness.

Eligibility criteria:
inclusion criteria * at least 18 years of age * self-identifying african american * self-reported current asthma * prescribed an inhaled corticosteroid (alone or combination) for ≥ 1 month * presented at a duke primary care clinic visit within the past 3 years or is establishing care at duke primary care * follow up duke primary care visit within the next 6 months exclusion criteria: * unable or unwilling to provide informed consent

Keywords: health disparities african american adult
risk-adapted donor lymphocyte infusion after allo-hsct in children with hematologic malignancy

Conditions: Hematologic Malignancy

Summary: allo-hsct is potentially curative method of treatment for children and adolescent with hematologic malignancy. however, relapses of disease after allo-hsct occur up to 50% of patients and constitute the main cause of mortality after hsct. donor lymphocytes infusion (dli) is a form of immunotherapy based on developement of reaction "graft versus from leukemia". this study evaluates the safety and efficacy of risk-adapted srtategy of dli for prophylaxis and prevention posttransplant relapses in children and adolescent with hematologic malignancy.


Eligibility criteria:
inclusion criteria: * age 4 months - 18 years old * diagnosis: acute lymphoblastic leukemia, acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, chronic myeloid leukemia * signed by legal representatives informed consent * high risk disease ( for all - initial hyperleukocytosis\> 50x109 / l, t-cell all, hypodiploid karyotype, complex karyotype, mll gene rearrangement, sil-tal deletion, primary resistent of the disease, early/very earle relapse, infant all; for aml patients - rearrangement of the mll gene (except for t (1; 11) and t (9; 11) with m5 morphology), inv (3), t (3; 3), complex karyotype anomalies, t (8; 21 ) with trisomy 4, t (16; 21), monosomy 7, monosomy 5, m7 without t (1; 22), flt3+, m6, t (7; 12), aml with multilineage dysplasia, p53 gene mutations, nup98 translocations, primary resistent of the disease, early/very earle relapse infant aml, secondary aml; all juvenile myelomonocytic leukemia and myelodysplastic syndrome; allo-hsct at 3 or more remission; persistence mrd before allohsct; allo-hsct out of remission; persistence mrd after allohsct; cytogenetic relapse after allohsct ) * donor chimerism=\>95% * no poor graft function (haemoglobin concentration \< 100 g/l; neutrophils \< 1.0 × 10e + 9/l; and platelets \< 30 × 10e + 9/l on day ≥ 30 post transplant with complete donor chimerism and no graft-versus-host disease or relapse ) * ecog 0-2 status * karnofsky/lansky status \>30% exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * severe organ failure: creatinine more than 2 norms; alt, ast more than 5 norms; bilirubin more than 1.5 norms * ejection fraction less than 50% * requirement for vasopressor support at the time of enrollment * somatic or psychiatric disorder making the patient unable to sign an informed consent * acute gvhd grade 3-4 in patient medical history * severe chronic gvhd in patient medical history

Keywords: allo-hsct children donor lymphocytei infusion
effects of non-invasive brain stimulation in tobacco use disorder

Conditions: Tobacco Use Disorder

Summary: the objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.


Eligibility criteria:
inclusion criteria: * tobacco use disorder (dsm-v) exclusion criteria: * other psychiatric disorders * contraindication to non-invasive brain stimulation and mri

Keywords: non-invasive brain stimulation tobacco use disorder craving
focus fatigue outcome in copaxone users

Conditions: Multiple Sclerosis

Summary: * the study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis. * secondary outcome measures are:disability, relapse rate, quality of life and depression.


Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis (ms), * at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment, * ambulant patients i.e disability score edss max 5,5, * clinically stable ms * relapse free and steroid free at least 30 days prior to start copaxone treatment exclusion criteria: * hypersensitivity to glatiramer acetate or mannitol, * pregnancy, * fertile female not willing to use effective contraception, * previous treatment with copaxone the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.